Point-and-click programming for deep brain stimulation using real-time monopolar review trendlines

ABSTRACT

A system and method for selecting leadwire stimulation parameters includes a processor iteratively performing, for each of a plurality of values for a particular stimulation parameter, each value corresponding to a respective current field: (a) shifting the current field longitudinally and/or rotationally to a respective plurality of locations about the leadwire; and (b) for each of the respective plurality of locations, obtaining clinical effect information regarding a respective stimulation of the patient tissue produced by the respective current field at the respective location; and displaying a graph plotting the clinical effect information against values for the particular stimulation parameter and locations about the leadwire, and/or based on the obtained clinical effect information, identifying an optimal combination of a selected value for the particular stimulation parameter and selected location about the leadwire at which to perform a stimulation using the selected value.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 15/420,842 filed Jan. 31, 2017, which is a divisional of U.S.patent application Ser. No. 15/012,698 filed Feb. 1, 2016, which issuedas U.S. Pat. No. 9,561,380 on Feb. 7, 2017, which is a divisional ofU.S. patent application Ser. No. 14/011,817 filed Aug. 28, 2013, whichissued as U.S. Pat. No. 9,248,296 on Feb. 2, 2016, which claims priorityto U.S. Provisional Patent Application Ser. Nos. 61/693,866 filed onAug. 28, 2012, 61/699,135 filed on Sep. 10, 2012, 61/699,115 filed onSep. 10, 2012, and 61/753,232 filed on Jan. 16, 2013, the content of allof which is hereby incorporated by reference herein in their entireties.

FIELD OF THE INVENTION

The present invention relates to a system and method for providing auser interface in which a representation of stimulation parameters of anelectrode leadwire, for example that provides electrical stimulation toan anatomical region, e.g., a leadwire of a Deep Brain Stimulation (DBS)device or a Spinal Cord Stimulation (SCS) device, is provided. Thepresent invention further relates additionally or alternatively to asystem and method, using software which provides a visualpoint-and-click interface that allows a user to optimize a subject's(e.g., patient's) stimulation parameters, without the user having tokeep track of the precise settings for each electrode.

BACKGROUND

Stimulation of anatomical regions of a patient is a clinical techniquefor the treatment of disorders. Such stimulation can include deep brainstimulation (DBS), spinal cord stimulation (SCS), Occipital NS therapy,Trigemenal NS therapy, peripheral field stimulation therapy, sacral rootstimulation therapy, or other such therapies. For example, DBS mayinclude stimulation of the thalamus or basal ganglia and may be used totreat disorders such as essential tremor, Parkinson's disease (PD), andother physiological disorders. DBS may also be useful for traumaticbrain injury and stroke. Pilot studies have also begun to examine theutility of DBS for treating dystonia, epilepsy, and obsessive-compulsivedisorder.

However, understanding of the therapeutic mechanisms of action remainselusive. The stimulation parameters, electrode geometries, or electrodelocations that are best suited for existing or future uses of DBS alsoare unclear.

For conducting a therapeutic stimulation, a neurosurgeon can select atarget region within the patient anatomy, e.g., within the brain forDBS, an entry point, e.g., on the patient's skull, and a desiredtrajectory between the entry point and the target region. The entrypoint and trajectory are typically carefully selected to avoidintersecting or otherwise damaging certain nearby critical structures orvasculature. A stimulation electrode leadwire used to provide thestimulation to the relevant anatomical region is inserted along thetrajectory from the entry point toward the target region. Thestimulation electrode leadwire typically includes multipleclosely-spaced electrically independent stimulation electrode contacts.

The target anatomical region can include tissue that exhibit highelectrical conductivity. For a given stimulation parameter setting, arespective subset of the fibers are responsively activated. Astimulation parameter can include a current amplitude or voltageamplitude, which may be the same for all of the electrodes of theleadwire, or which may vary between different electrodes of theleadwire. The applied amplitude setting results in a correspondingcurrent in the surrounding fibers, and therefore a corresponding voltagedistribution in the surrounding tissue. The complexity of theinhomogeneous and anisotropic fibers makes it difficult to predict theparticular volume of tissue influenced by the applied stimulation.

A treating physician typically would like to tailor the stimulationparameters (such as which one or more of the stimulating electrodecontacts to use, the stimulation pulse amplitude, e.g., current orvoltage depending on the stimulator being used, the stimulation pulsewidth, and/or the stimulation frequency) for a particular patient toimprove the effectiveness of the therapy. Parameter selections for thestimulation can be achieved via tedious and variable trial-and-error,without visual aids of the electrode location in the tissue medium orcomputational models of the volume of tissue influenced by thestimulation. Such a method of parameter selection is difficult andtime-consuming and, therefore, expensive. Moreover, it may notnecessarily result in the best possible therapy.

Systems have been proposed that provide an interface that facilitatesparameter selections. See, for example, U.S. patent application Ser. No.12/454,330, filed May 15, 2009 (“the '330 application”), U.S. patentapplication Ser. No. 12/454,312, filed May 15, 2009 (“the '312application”), U.S. patent application Ser. No. 12/454,340, filed May15, 2009 (“the '340 application”), U.S. patent application Ser. No.12/454,343, filed May 15, 2009 (“the '343 application”), and U.S. patentapplication Ser. No. 12/454,314, filed May 15, 2009 (“the '314application”), the content of each of which is hereby incorporatedherein by reference in its entirety.

Such systems display a graphical representation of an area within whichit is estimated that there is tissue activation or volume of activation(VOA) that results from input stimulation parameters. The VOA can bedisplayed relative to an image or model of a portion of the patient'sanatomy. Generation of the VOA may be based on a model of fibers, e.g.,axons, and a voltage distribution about the leadwire and on detailedprocessing thereof. Performing such processing to provide a VOA previewin real-time response to a clinician's input of parameters is notpractical because of the significant required processing time.Therefore, conventional systems pre-process various stimulationparameter settings to determine which axons are activated by therespective settings.

Those systems also provide interfaces via which to input selections ofthe stimulation parameters and notes concerning therapeutic and/or sideeffects of stimulations associated with graphically represented VOAs.

The leadwire can include cylindrically symmetrical electrodes, which,when operational, produce approximately the same electric values in allpositions at a same distance from the electrode in any plain that cutsthrough the electrode. Alternatively, the leadwire can includedirectional electrodes that produce different electrical valuesdepending on the direction from the electrode. For example, the leadwirecan include multiple separately controllable electrodes arrangedcylindrically about the leadwire at each of a plurality of levels of theleadwire.

Each electrode may be set as an anode or cathode in a bipolarconfiguration or as a cathode, with, for example, the leadwire casingbeing used as ground, in a monopolar arrangement. When programming aleadwire for tissue stimulation, e.g., DBS, the clinical standard ofcare is often to perform a monopolar review (MPR) upon activation of theleadwire in order to determine the efficacy and side-effect thresholdsfor all electrodes on the leadwire, on an electrode by electrode basis.Monopolar review, rather than bipolar review, is performed becausemonopolar stimulation often requires a lower stimulation intensity thanbipolar stimulation to achieve the same clinical benefit. The MPR caninform the selection of a first clinical program (parameters forstimulation) for treating a patient. For example, in a single currentsource, voltage-controlled DBS device, a time-consuming review isperformed involving sequentially measuring efficacy and side-effectthresholds for all electrodes of a leadwire and recording thesethreshold values. Such a tedious review is described in Volkmann et al.,Introduction to the Programming of Deep Brain Stimulators, MovementDisorders Vol. 17, Suppl. 3, pp. S181-S187 (2002) (“Volkmann”). See, forexample, FIG. 3 of Volkmann and the corresponding text, which describesgradually increasing amplitude separately for each of a plurality ofelectrodes, and recording the amplitude at which a minimum threshold oftherapeutic efficacy is observed, and the maximum amplitude that doesnot exceed a permitted adverse side-effect threshold.

SUMMARY

According to example embodiments, a leadwire includes multipleelectrodes, for each of which a respective independent current source isprovided, by which current can be “steered” longitudinally and/orrotationally about the leadwire for localization of stimulation atpoints between electrodes (such a point hereinafter referred to as a“virtual electrode”). The electrical variation about a leadwire producedby virtual electrodes creates an added layer of complexity concerningstimulation parameters and their effects. Example embodiments of thepresent invention provide a visual point-and-click interface thatincludes a graphical representation of a stimulation parameter forvirtual electrodes, via which to input settings therefor, and/or viawhich to obtain and/or output annotations concerning stimulationparameters thereof. According to example embodiments of the presentinvention, the interface includes controls for gradual directionalsteering of current about the leadwire, without the requirement forseparately setting individual electrical amplitude settings of theindividual electrodes, where the steering occurs between actual andvirtual electrodes, the interface further providing for the system toreceive input of efficacy and adverse side effect information. Accordingto an example embodiment, the obtained input is recorded in associationwith the settings for which the input was provided, the system therebygenerating longitudinal and/or rotational maps of efficacy and sideeffect information arranged about the leadwire according to the actualand/or virtual electrode positions with which the efficacy and sideeffect information are associated.

Thus, according to an example embodiment of the present invention, thesystem performs an iterative process, where each iteration correspondsto a single selected stimulation parameter value, e.g., amplitude, towhich value a respective electric field corresponds. For each iteration,the electric field is shifted to various actual and/or virtual electrodelocations about the leadwire, and for each of a plurality of thelocations to which the respective field of the iteration has beenshifted, clinical information regarding therapeutic effect and/oradverse side effect for a stimulation produced by the electric field isrecorded. After completion of an iteration, the value of the parameteris changed for a new iteration, in which the shifting and informationrecording is repeated for the new value. The information obtained duringa plurality of the iterations is then usable for construction of a graphon which basis optimal settings are selectable. Such settings include,in an example embodiment, a combination of respective values of theparameter for a selected subset of electrodes of the leadwire.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. The drawingsillustrate generally, by way of example, but not by way of limitation,various embodiments discussed in the present document.

FIG. 1 shows graphs providing stimulation amplitude information forcylindrically symmetrical electrodes, according to an example embodimentof the present invention.

FIG. 2 shows an example leadwire model that is displayable by a systemin a user interface, and further shows relative thereto a coordinatesystem for indicating amplitude information for directional electrodes,according to an example embodiment of the present invention.

FIG. 3 shows amplitude information graphs for directional electrodes ina three-dimensional perspective, according to an example embodiment ofthe present invention.

FIG. 4A shows a slider control for rotating a leadwire model, accordingto an example embodiment of the present invention.

FIG. 4B shows left and right buttons for rotating a leadwire model,according to an example embodiment of the present invention.

FIG. 4C shows a draggable interface component for rotating a leadwiremodel, according to an example embodiment of the present invention.

FIG. 4D shows a user interface control including a ray that isuser-draggable rotationally about a point of origin corresponding to aleadwire and inward and outward with respect to the point of origin, foruser modification of electrical parameters, according to an exampleembodiment of the present invention.

FIG. 5 illustrates user interface components, by user interaction withwhich a system is configured to receive input of stimulation parameters,according to an example embodiment of the present invention.

FIG. 6 illustrates user interface components, by user interaction withwhich a system is configured to receive input of annotations regardingstimulation settings, according to an example embodiment of the presentinvention.

FIG. 7 illustrates user interface components for outputting variationsin effect for variations in amplitude in a particular direction,according to an example embodiment of the present invention.

FIG. 8 illustrates a user interface display of information concerningsuitable stimulation amplitude parameters for directional electrodesusing graphs in a three-dimensional perspective, according to an exampleembodiment of the present invention.

FIGS. 9A and 9B show user interface displays of the graphs of FIG. 8 ina two-dimensional perspective, according to an example embodiment of thepresent invention.

FIGS. 10A and 10B show graphs providing stimulation amplitudeinformation for cylindrically symmetrical electrodes, according to anexample embodiment of the present invention.

FIG. 11 shows an example leadwire model that is programmed by a systemvia a user interface, and further shows relative thereto, location andcurrent level information for stimulation at a specified amplitude,according to an example embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1 shows an example graphical user interface display of outputindicating amplitude information for stimulation using a cylindricallysymmetric leadwire. With respect to a cylindrically symmetric leadwire,in an example embodiment, a graph is output in which stimulationamplitude values are plotted, for both a therapy onset curve 101 andside effect onset curve 102, against electrode location, where theelectrode locations refer to longitudinal positions of the leadwire. Forexample, discrete positions along the abscissa can correspond torespective electrodes of the leadwire in their order of arrangementalong the leadwire.

Alternatively, different combinations of amplitudes of the electrodescan be set, where each combination can be characterized as having anamplitude setting at a respective longitudinal position of the leadwire,producing a cylindrically symmetric stimulation about the leadwire atthat respective longitudinal leadwire position. Positions along theabscissa can represent discrete locations from a first position of theleadwire towards another position of the leadwire, where some of thelocations can be those of respective ones of the cylindricallysymmetrical electrodes, and others can be other locations correspondingto the combination of stimulation settings of a plurality of theelectrodes.

The therapy onset curve 101 indicates amplitude thresholds at which atherapeutic result is expected, depending on the electrode orlongitudinal leadwire position at which the respective stimulationamplitude is set. The side effect onset curve 102 indicates a maximumstimulation amplitude at respective electrode or longitudinal leadwirepositions, above which the stimulation is expected to cause an adverseside effect. Information on which the curves 101 and 102 are based caninclude empirically obtained data and/or model-based data. The graphs101 and 102 can be specific to an indicated desired therapy and/or to anindicated adverse side effect. For example, the graphical userinterface, e.g., in a target settings section, can include an inputfield for inputting a desired therapeutic effect and/or side effect tobe avoided, and output a graph such that shown in FIG. 1 as informationon which the user, e.g., a clinician, can determine settings to set inthe system for producing a stimulation.

Such graphs can be useful for a clinician to eyeball a target range ofpossible target settings for one or more of the electrodes. For example,the clinician likely would choose to try an amplitude settings thatfalls at about the center of the shaded area 105 between the curves 101and 102 since it is that region that is expected to produce atherapeutic effect and to avoid production of an adverse side effect.

However, such a representation does not reflect variations in amplitudeat different directions cylindrically about the leadwire usingdirectional electrodes. According to an example embodiment of thepresent invention, the system and method outputs stimulation amplitudeinformation in a coordinate system in which each plotted data point isidentified by a longitudinal position ‘z’, angle of rotation ‘θ’, andradius from center ‘r’, where the longitudinal position is thelongitudinal position along the central axis of the leadwire, e.g., adistance from one of the ends, the angle of rotation is an angle betweena selected direction extending outward from the leadwire,perpendicularly to the central axis thereof, and the direction in whichstimulation is characterized as being produced by an electrode (orcombination of electrodes), and radius is a distance from the leadwirealong the direction in which the stimulation is characterized as beingproduced. The radius coordinate corresponds to the stimulation amplitudevalue, whereas the longitudinal position and angle of rotationinformation indicates the location of that stimulation. In an exampleembodiment of the present invention, a computer system provides agraphical user interface in which amplitude settings for a directionalelectrode leadwire are plotted in curves at planes that areperpendicular to the central axis of the leadwire according to thedescribed coordinate system including longitudinal, angular, and radiivalues.

FIG. 2 shows an example leadwire that includes a plurality ofdirectional electrodes. In FIG. 2, the example leadwire 200 includes, ata first longitudinal level of the leadwire, three directional electrodes201, 202, and 203, at a second longitudinal level of the leadwire, threedirectional electrodes 206, 207, and 208, and, at a third longitudinallevel, a cylindrically symmetrical electrode 211 that is configured forgenerating a stimulation at approximately equal levels about theleadwire 200. While the directional electrodes are shown to be providedin groups about the leadwire, in an example embodiment, the leadwire 200includes a circumferential directional electrode that continuouslyextends around the leadwire, but is controllable for generatingstimulations at different levels in different directions from theleadwire.

FIG. 2 further shows a coordinate system in which amplitude values canbe plotted using the ‘z’, ‘0’, and ‘r’ coordinates. The coordinatesystem is shown relative to the illustrated leadwire 200, therebyshowing the meaning of the coordinate values, which represent positionaland amplitude information relative to the leadwire 200. Although theleadwire 211 is not a directional leadwire, the same coordinate systemcan be used for the cylindrically symmetrical leadwire too.

FIG. 3 shows an example user interface display of graphed amplitudesettings values using the described coordinate system for a directionalleadwire. For example, a graph 302 and/or 304 is drawn with aperspective of being in a two dimensional plane perpendicular to theleadwire 200. Each of the illustrated graphs includes a shape formed byplotted values, for example, representing therapeutic threshold minimumvalues, i.e., values estimated as the minimum required amplitude forstimulation, where the estimated threshold minimum values vary dependingon direction from the leadwire 200 at the longitudinal position of theleadwire 200 at which the plane is drawn. The graphs can alternativelyrepresent maximum amplitude values above which a side effect isestimated to occur. As described below, graphs showing a combination ofthis information can also be provided.

Stimulation using a combination of electrodes at an one longitudinallevel can produce stimulation values characterized by a stimulation at adirection which can be between the electrodes. Similarly, stimulationusing a combination of electrodes at a plurality of longitudinal levelscan produce stimulation values characterized by a stimulation at a levelbetween electrodes above and below. Therefore, the displayed graphs neednot be a longitudinal positions at which there are electrodes (althoughan alternative example embodiment can be provided in which the graphsare displayed only at longitudinal positions at which at least oneelectrode is located). In an example embodiment, using graphs plottingstimulations values characterized as occurring between electrodes bycombinations of stimulations of those electrodes, the system plots aplurality of two dimensional graphs of stimulation values in a pluralityof continuous layers to form a three dimensional graph volume.

In an example embodiment of the present invention, the system displays amodel of the leadwire 200, e.g., as shown in FIG. 2 and further displaysone or more graphs as shown in FIG. 3. The graphs can be displayed in aseparate display area as that in which the model of the leadwire 200 isdisplayed, or can be displayed overlaid on the model of the leadwire200. In an example embodiment of the present invention, the system andmethod of the present invention provides a graphical user interfaceincluding view rotation controls, by which a user can rotate thedisplayed model of the leadwire 200 and the displayed graphs.

For example, FIG. 4A shows a slide bar 400, with the center set at 0°,the right end at +180°, and the left end at −180°. A particularlongitudinal line at a predetermined point along the circumference ofthe leadwire is selected as corresponding to 0°. The user can shift aslider control 402 along the slider bar 400, in response to which thesystem correspondingly rotates the model of the leadwire 200 (and theassociated graphs). For example, in an example embodiment, the systemshifts the model of the leadwire 200 so that that the selected angularportion of the leadwire 200 is positioned parallel with the surface ofthe screen in which the user interface is displayed.

Alternatively (or additionally), as shown in FIG. 4B, a right button 405and a left button 406 can be displayed, which buttons are selectableusing an input device, e.g., via point and click, touch, or any othersuitably appropriate selection device/method, in response to whichselection the model of the leadwire 200 is rotated towards the right ortowards the left by a predetermined number of degrees per selection. Inan example embodiment, the system displays an indication of the numberof degrees the model of the leadwire 200 has been rotated, for example,as shown in FIG. 4B, between the selectable right and left buttons405/406.

Alternatively (or additionally), as shown in FIG. 4C, the model of theleadwire 200 or a separate leadwire rotation control 410 that isselectable by the user and draggable to the right or to the left isdisplayed, where, in response to the dragging of the leadwire model 200or the separate rotation control 410, the system correspondingly rotatesthe model of the leadwire 200 and the graphs. In an example embodiment,as shown in FIG. 4C, the system displays an indication of the number ofdegrees the model of the leadwire 200 has been rotated, for example, asshown in FIG. 4C, in a top cross-section of the leadwire representationof the leadwire rotation control 410.

In an example embodiment of the present invention, representations ofrespective electrodes in the model of the leadwire 200 or in theleadwire rotation control 410 are selectable, in response to whichinput, the system is configured to obtain user input of one or moresettings to be set for the selected electrode. In an example embodiment,the system is configured to display one or more data fields in which toinput parameter values for the selected electrode. In an exampleembodiment, as shown in FIG. 4D, the system is configured to display aray 415 extending from the selected electrode, which ray 415 the usercan select and drag in a direction away from the representation of theleadwire 200 or towards the representation of the leadwire 200, wherethe system interprets dragging in the direction away from therepresentation of the leadwire 200 as an input to increase the amplitudesetting, and the system interprets dragging back toward therepresentation of the leadwire 200 as an input to decrease theamplitude. The input can be by a clinician and, in an exampleembodiment, the system is configured to receive an instruction inresponse to which the system is configured to apply the modified settingto an implanted pulse generator that causes the leadwire 200 to producethe stimulation. Alternatively or additionally, the user-modification ofthe settings is for input of stimulation programs for which the systemoutputs information, e.g., a VOA, and/or other information, based onwhich the user can select a program to apply to the implanted pulsegenerator.

In an example embodiment of the present invention, the user interfacedisplay including the model of the leadwire 200 further includes a ray,like described ray 415, that extends from the model of the leadwire 200,and the ray is selectable and draggable towards the right and towardsthe left to modify a directionality of a stimulation, and inwards andoutwards with respect to the model of the leadwire 200 to modify anamplitude of the stimulation in the selected direction.

FIG. 5 shows a part of a graphical user interface, according to anexample embodiment, that can be displayed in a display device and thatincludes controls selectable by a user for input of stimulationsettings, including a directionality, amplitude, and longitudinallocations relative to the leadwire, for a stimulation. The userinterface includes a rotate left button 500, for modifying by the systemof the directionality of a stimulation by clockwise rotation about theleadwire by a predetermined incremental amount, responsive to eachselection thereof. The user interface further includes a rotate rightbutton 502, for modifying by the system of the directionality of thestimulation by counter-clockwise rotation about the leadwire by apredetermined incremental amount, responsive to each selection thereof.The user interface further includes one or more slider bars by which tomodify the amplitude of the stimulation. For example, as shown in FIG.5, in an example embodiment the user interface includes a coarse sliderbar 510 in response to sliding of the slider control of which, thesystem modifies the amplitude by a first predetermined amount, e.g., asingle digit whole number, for each change in position of the slidercontrol; and also includes a fine slider bar 512 in response to slidingof the slider control of which, the system modifies the amplitude by asecond predetermined amount smaller than the first predetermined amount,for fine increments between the selected coarse value set by theposition of the coarse slider bar 510 and the next higher coarse valuecorresponding to the position of the coarse slider bar 510 that followsthe current position thereof. For example, the coarse slider bar 510 canbe set to be shifted between positions 0 and 12, a single whole numberat a time, and the fine slider bar 512 can be set to be shifted betweenpositions 0.0 and 0.9, a tenth at a time, so that for whichever value isset by the coarse slider bar 510, the value is further settable to anadditional fractional amount.

The user interface further includes an up button 504 and a down button506, for selection by the user of the longitudinal location along theleadwire at which the stimulation is to occur.

In an example embodiment, as shown in FIG. 5, the user interface furtherincludes a, e.g., two dimensional, settings map 515 that shows presentvalues of the settings with respect to directionality and amplitude ofthe stimulation. The settings map 515 includes a respectiverepresentations 516 a-516 c of each electrode at a particularlongitudinal level. The settings map 515 includes a bar 518 angularlypositioned according to the directionality of the stimulations accordingto the present settings, and whose length corresponds to the presentlyset amplitude of the stimulation. As the user provides input, e.g., viacontrols 500, 502, 510, and 512, to modify the directionality and/oramplitude, the bar 518 is rotated and/or shortened or lengthened. In anexample embodiment, as shown in FIG. 5, the present angle and amplitudeare displayed in the settings map 515.

In an example embodiment of the present invention, the user interfaceshown in FIG. 5, described above, instead of providing forlongitudinally steering the electrical, e.g., current, using the up anddown buttons 504 and 506, the system provides for receiving respectiveinput for each longitudinal level of electrodes, each respective inputindicating a respective direction and amplitude, e.g., by use of thecontrols 500, 502, 510, and/or 512, and/or other input controls, e.g.,as described herein. For example, for the leadwire 200 as shown in FIG.2, which includes electrodes 201-203 at a first level, electrodes206-208 at a second level, and electrode 211 at a third level, thesystem outputs three user interface sections, e.g., like that shown inFIG. 5, for separately inputting the directional and amplitude settingsof the stimulation.

According to a variant of this embodiment, the buttons 504 and 506 areomitted since current steering is not supported. Alternatively, buttons504 and 506 are provided, but, according to this embodiment, theirselections do not cause the above-described current steering, but ratherare used for traversing between settings of different electrode levelsof the leadwire. For example, the user can use the controls shown inFIG. 5 (or other controls) to set the direction and amplitude forelectrodes at a first longitudinal level of the leadwire, and thenselect one of buttons 504 and 506 to set the settings for the electrodesof, respectively, the next higher or lower longitudinal level of theleadwire.

In an example embodiment of the present invention, the stimulationcontrols and the settings map 515 are displayed in an interface in whicha three-dimensional perspective of a model of the leadwire 200, e.g., asshown in FIG. 2, is also displayed, which model is rotatable, forexample, as discussed above with respect to any of FIGS. 4A-4C, and therotational orientation of the settings map 515 is set by the system tocorrespond to the rotational orientation of the three-dimensionalperspective of the model of the leadwire 200, such that the settings map515 is rotated when the three-dimensional perspective of the model isrotated.

As described above with respect to FIG. 3, according to exampleembodiments of the present invention, the system displays one or moregraphs providing certain threshold (e.g., minimums and/or maximums)information using longitudinal, angular, and radii coordinates,regarding stimulation at various directions about the leadwire. In anexample embodiment of the present invention, the system includes aninteractive user interface with which a user can interact to inputinformation usable by a processor to generate graphs such as thosedescribed with respect to FIG. 3. For example, FIG. 6 shows an exampleannotation control interface including annotation controls selectable bya user for inputting information concerning presently indicatedsettings. For example, in an example embodiment, the annotation controlinterface includes a sub-therapeutic button 600, which, if selected bythe user, causes a processor of the system to record in memoryinformation indicating that a stimulation at the presently indicatedsettings fail to produce a sufficiently therapeutic effect. In anexample embodiment, the annotation control interface additionally oralternatively includes a therapeutic button 602, which, if selected bythe user, causes a processor of the system to record in memoryinformation indicating that a stimulation at the presently indicatedsettings fail produce a sufficiently therapeutic effect. In an exampleembodiment, the annotation control interface additionally oralternatively includes an over limit button 604, which, if selected bythe user, causes a processor of the system to record in memoryinformation indicating that a stimulation at the presently indicatedsettings produces an adverse side effect.

A therapy can cause both a therapeutic effect and an adverse sideeffect. Therefore, according to an example embodiment of the presentinvention, the system allows for input indicating both the therapeuticeffect and the side effect.

According to an alternative example embodiment of the present invention,the annotation control interface includes a list of symptoms with anassociated one or more input fields or selectable controls (e.g.,discrete or by slider bar) by which to indicate a degree of therapeuticeffect for that respective symptom and/or a list of adverse side effectswith an associated one or more input fields or selectable controls(e.g., discrete or by slider bar) by which to indicate a degree to whichthe respective side effect is caused by the stimulation at the presentlyindicated settings. For example, as shown in FIG. 6, a symptoms section606 lists the example symptoms of “tremor” and “bradykinesia” alongsideeach of which is a respective series of buttons selectable for inputtinga respective degree of therapeutic effect for the respective symptom.For example, FIG. 6 shows a set of 5 buttons 606 a-606 e for inputtingrespective degrees of therapeutic effect for the symptom of tremor, forexample, where selection of button 606 a indicates a highest therapeuticeffect and selection of button 606 e indicates a lowest therapeuticeffect (buttons 606 b-606 d indicating intermediate and progressivelydecreasing therapeutic effect). FIG. 6 similarly shows a set of 5buttons 616 a-616 e similarly operable for the symptom of bradykinesia.FIG. 6 similarly shows a side effect section 626 which lists the exampleadverse side effect of “dysarthia” alongside which is a respective setof 5 buttons 626 a-626 e for inputting respective degrees of the adverseside effect of dysarthria, for example, where selection of button 626 aindicates a lowest amount of side effect and selection of button 626 eindicates a highest amount of side effect (buttons 626 b-626 dindicating intermediate and progressively increasing side effect).

In an example embodiment of the present invention, the controls forinputting specific therapeutic and side effect information, includingidentification of particular symptoms for which therapeutic effect isprovided and/or identification of particular adverse side effectsproduced by the therapy, such as controls of sections 606 and 626, andthe controls for inputting the more generalized information as towhether a therapeutic effect has been provided and/or a side effect hasbeen produced, such as controls 600-604 are all provided by the system.For example, in an example embodiment of the present invention, thesystem initially displays controls 600-604, and, responsive to selectionof a “details” button or tab 605, the system displays the controls forinputting the information in detailed form. For example, the systemupdates the interface to simultaneously display all of the controls600-604 and 606 a-626 e. Alternatively, the system responsively replacesthe generalized controls with the more specific controls. According toeither embodiment, the system, in an example embodiment, toggles betweenthe two types of displays responsive to repeated selection of thedetails button 605.

According to an example embodiment of the present invention, the systemis configured to output different graphs as described with respect toFIG. 3 depending on user selectable filter criteria. For example, theuser can filter for therapeutic effect related to tremor, in response towhich filter the system is configured to output graphs like those shownin FIG. 3 indicating direction-dependent minimum amplitude values forproducing a therapeutic effect for tremor, or can similarly filter fortherapeutic effect related to bradykinesia. In an example embodiment,without input of a filter criterion, the system outputs a graph basedon, for example, minimum amplitude values for producing a therapeuticeffect of any kind, i.e., not limited to any one type of selectedtherapeutic effect.

Similarly, in an example embodiment of the present invention, the usercan filter by adverse side effect, e.g., by dysarthia, in response towhich filter the system is configured to output graphs like those shownin FIG. 3 indicating direction-dependent maximum amplitude values abovewhich the particular selected side effect is expected to occur. In anexample embodiment, without input of a filter criterion, the systemoutputs a graph based on, for example, maximum amplitude values beyondwhich any side effect has been recorded to have occurred, i.e., notlimited to any one type of selected side effect.

Similarly, instead of or in addition to filtering by type of therapeuticeffect and/or side effect, the system provides for filtering based ondegree. For example, referring to FIG. 6, the user can filter for onlythose therapeutic effects indicated by at least a strength of thatrepresented by button 606 c, etc. Another example filter criterion istime. For example, the user can filter for graph generation based oninput provided in a user-selected time period.

According to an example embodiment, if information is entered indicatingthe occurrence of a therapeutic effect or side effect, withoutadditional details, e.g., by operation of one or more of the buttons600-604, without providing additional details concerning degree or type,the system uses such information for the generation of a graphunconstrained by the above-described input criterion of degree and/ortype, but does not consider such information for graphs provided inresponse to a user request constrained by such input criteria.

In an example embodiment of the present invention, the system isconfigured to output a combination of discrete graphs corresponding torespective types and/or degree. For example, in a plane drawn at aparticular longitudinal position of the leadwire, the system outputs oneor more graphs corresponding to therapeutic effect for tremor (at one ormore degrees of effect) and one or more graphs corresponding totherapeutic effect for bradykinesia (at one or more degrees of effect).The system outputs indicia that identify the effect (and/or degreethereof) to which the different graphs correspond. For example,different colors (and/or hue, saturation, and/or transparency) can beused to represent different effects, and/or different labels can bedisplayed, e.g., perpetually or when selected or when a pointer is movedover or in close proximity to the graph. The system can similarlygenerate a plane of overlapping graphs corresponding to different sideeffects (and/or side effect seventies).

In an example embodiment of the present invention, instead of or inaddition to a user interface display in which a plurality of graphs fordifferent therapeutic effects, and/or side effects, and/or degreesthereof are included in a single plane, the graphs indicatingdirectional dependency of the amplitude about the leadwire, the systemis configured to indicate a variation of stimulation effect (e.g.,adverse side effect or therapeutic effect) along a single selecteddirection from the leadwire as amplitude is increased. For example, FIG.7 shows a user interface display including a model of a leadwire 200with a ray 700 including markings at different locations of the raycorresponding to respective distances from the leadwire, which furthercorresponds to respective amplitude values. The markings can be providedat equal intervals. Alternatively, the markings can be provided whereverthere is an appreciable change to the effect (e.g., where the system isprogrammed to indicate where a predefined difference value or percentageis reached). In an example embodiment, the markings indicate the degreeof effect. For example a textual label or other indicia can be used.Further, in an example embodiment, a single ray is marked with differenttypes of indicia for different types of information, e.g., differentside effects or therapeutic effects. For example, ray 700 is marked bysquares 701 a-701 c and triangles 703 a-703 c of different sizes, wheresquares 701 a-701 c indicate one type of effect, e.g., therapeuticeffect for tremor, and triangles 703 a-703 c indicate another type ofeffect, e.g., therapeutic effect for bradykinesia, and where the sizesindicate the degree of such effect, e.g., small shapes indicating aslight effect and large shapes indicating a large effect.

While FIG. 7 shows a single ray 700 in a single direction, in an exampleembodiment, the system displays a plurality of such rays, each in arespective direction. For example, in an example embodiment, the systemgenerates a display with a plurality of evenly spaced rays cylindricallyabout the leadwire. In an alternative example embodiment, the system isconfigured for receiving user input of one or more angles (i.e.,directions), and the system accordingly displays respective rays foreach of the input angles. In an example embodiment, the system, bydefault outputs a single ray for each directional electrode.

As shown in FIG. 8, in an example embodiment of the present invention,the system is configured to output, in a single plane, graphs for boththerapeutic effect and adverse side effect, which graphs can overlapdepending on the respective minimum and maximum amplitude values of thegraphs in the different directions about the leadwire. A user canthereby determine a range of amplitudes and an angular range about theleadwire at which to set the stimulation. In an example embodiment, thesystem is configured to mark a graph region determined to be suitablefor stimulation based on the relationship between the area of the twographs (where the graphs do indicate the existence of such a region).

For example, FIG. 8 shows a therapy onset graph 800 and a side effectsgraph 802 within a plane at longitudinal position z1. In an exampleembodiment, the system outputs indicia indicating which graph representstherapy onset values and which graph represents adverse side effects,each by line type or color and/or textual indicia, etc. It furtherincludes a cross-hatched region 805, the cross-hatching indicating thatregion to represent suitable stimulation parameters. Any other suitablyappropriate region indicia can be used, e.g., highlighting, coloring, ortextual indicia, etc. The cross-hatched region is determined torepresent suitable parameters because the parameters corresponding tothat region are indicated to produce a therapeutic effect withoutproducing an adverse side effect.

FIG. 8 further shows a therapy onset graph 808 and a side effects graph810 within a plane at longitudinal position z2. No cross-hatched regionis included because there is no suitable range of stimulation parametersat longitudinal position z2, since, in all directions about theleadwire, intolerable side effects set in at lower amplitudes than thoseat which therapeutic effects are first attained.

It is noted that that there may be certain adverse side effects that aretolerable and there may be certain therapeutic effects that areinsignificant. The system is programmed to produce the graphicalinformation for certain predetermined side effects and/or therapeuticeffects. Additionally, in an example embodiment, the system includes auser interface via which a user can select one or more side effectsand/or one or more therapeutic effects on which basis to generate thegraphs.

When the graphs are provided in a three-dimensional perspective aboutthe model of the leadwire 200, the leadwire model can partially obscureportions of the graphs. Although, as discussed above, exampleembodiments provide a control for rotating the model, so that the graphscan be rotated and viewed at the different angles, a user may desire toview entire graphs at a time for the respective longitudinal positionsat which they are generated. Additionally, when the graphs are providedin a three-dimensional perspective, precise dimensions of the graphshape are distorted to account for depth in a two-dimensional displayscreen, for example, as can be seen by a comparison of the graphs inFIG. 8 and their two-dimensional perspective counterparts shown in FIGS.9A and 9B. Accordingly, in an example embodiment of the presentinvention, the system displays the graphs in a two dimensional view, inwhich the graphs of a single longitudinal position are displayed suchthat planes formed by the graphs are parallel to the surface of thedisplay area, e.g., parallel to the surface of a display screen. Forexample, FIG. 9A shows the graphs 800 and 802 in a two-dimensional viewwith the leadwire virtually extending perpendicularly to the displayscreen, and FIG. 9B shows the graphs 808 and 810 in a two-dimensionalview with the leadwire virtually extending perpendicularly to thedisplay screen. In an example embodiment of the present invention, atwo-dimensional view of graphs is displayed for only a single one of thelongitudinal positions of the leadwire at any one time. Alternatively,in an example embodiment, different two-dimensional graph views for aplurality of longitudinal positions are simultaneously displayed indifferent respective display areas of the display screen, e.g., eacharea including respective indicia indicating the respective longitudinalposition to which it corresponds.

In an example embodiment of the present invention, the system displays amodel of the leadwire 200, e.g., as shown in FIG. 2 and further displaysone or more graphs as shown in FIGS. 10A and 10B (described below). Thegraphs can be displayed in a display area separate from that in whichthe model of the leadwire 200 is displayed, or can be displayed overlaidon the model of the leadwire 200. In an example embodiment of thepresent invention, the system and method of the present inventionprovides a graphical user interface including longitudinal steeringcontrols and/or rotational steering controls, by which a user can, for agiven fixed parameter (e.g., amplitude, pulse width, frequency, etc.),steer stimulation longitudinally up and down the electrodes of theleadwire and/or rotationally around the electrodes of the leadwire 200,including between actual and/or virtual electrodes, a processhereinafter referred to as e-trolling. At a plurality of arbitrarypoints (e.g., actual and/or virtual electrode) along the leadwiretraversed via e-trolling, the efficacy and side-effects of a stimulationare evaluated. For example, if the patient exhibits undesireableside-effects, the user can annotate the stimulation at the actual orvirtual electrode as being in a “side-effect range” by clicking on abutton or menu item of the user interface, for example, using controlssuch as those shown in FIG. 6. Accordingly, if the patient exhibits goodsymptom relief or therapeutic efficacy, the user can annotate thecurrent setting as being in an “efficacy range” by clicking on a buttonor menu item.

As explained above, FIG. 5 shows a part of a graphical user interface,according to an example embodiment, that can be displayed in a displaydevice and that includes controls selectable by a user for input ofstimulation settings, including a directionality, amplitude, andlongitudinal locations relative to the leadwire, for a stimulation. Theuser interface includes a rotate left button 500, for modifying by thesystem of the directionality of a stimulation by clockwise rotationabout the leadwire by a predetermined incremental amount, responsive toeach selection thereof. The user interface further includes a rotateright button 502, for modifying by the system of the directionality ofthe stimulation by counter-clockwise rotation about the leadwire by apredetermined incremental amount, responsive to each selection thereof.The user interface further includes an up button 504 and a down button506, for selection by the user of the longitudinal location along theleadwire at which the stimulation is to occur. In the case of a leadwire200 with only non-directional, circumferential (cylindricallysymmetrical) electrodes only an up button 504 and a down button 506, forselection by the user of the longitudinal location for stimulation alongthe leadwire, are provided or are active. (As noted above, the up anddown buttons 504 and 506, according to an alternative exampleembodiment, provide for selecting a longitudinal level at which to setcurrent information for the electrodes at that level.)

According to an example embodiment, information concerning therapeuticeffect and/or adverse side effect is additionally or alternativelyobtained using sensors. For example, a sensor can be used to sensepatient tremor, speed, stability, heart rate, etc., based on whichsensed information conclusions concerning therapeutic effect and/or sideeffect are automatically made and recorded.

Thus, according to an example embodiment of the present invention, auser interface facilitates gradual steering of a current, e.g., at acertain amplitude, frequency, and/or pulse width, about the leadwire,and user annotation of the steered current at various actual and/orvirtual electrodes at which the current has been steered, as being in an“efficacy range” or a “side-effects range,” by clicking a button or menuitem for those electrode locations. According to an example embodiment,the determination of whether the steered current, at an actual and/orvirtual electrode at which the current has been steered, is in an“efficacy range” or a “side-effects range” is performed by a processorbased on information concerning therapeutic effect and/or adverse sideeffect additionally or alternatively obtained using sensors. Accordingto an example embodiment, the system records the input (and/or sensor)information in association with the electrode locations to which theycorrespond, and, based on the recorded information regarding arespective plurality of actual and/or virtual electrodes traversed viae-trolling, generates a curve that connects the annotated values foreach such respective identified and annotated actual and/or virtualelectrode, thereby graphically identifying the totality of the results(for a given stimulation parameter setting) for a set of electrodes ofthe leadwire 200 as shown in FIG. 10A. The generated curve includesestimated data for connecting the discrete respective valuescorresponding to the respective identified and annotated actual and/orvirtual electrodes. The set of electrodes can include severalcylindrically symmetrical electrodes arranged longitudinally along theleadwire 200 and/or can include several directional electrodes arrangedcircumferentially around the leadwire 200 at a same longitudinal levelon the leadwire 200.

Similar to that shown in FIG. 1, FIG. 10A shows an example graphicaluser interface display of output indicating amplitude information forstimulation using a leadwire with cylindrically symmetricalcircumferential electrodes. The graph is based on the recordedinformation regarding a respective plurality of actual and/or virtualelectrodes traversed via e-trolling and includes a therapy onset(efficacy) curve 101 and a side effect onset (side effect) curve 102that plot stimulation amplitude values for therapy onset (e.g., meetinga minimum threshold) and side effect onset (e.g., meeting a minimumthreshold), against actual and virtual electrode locations,corresponding to longitudinal positions along the leadwire. For example,discrete positions along the abscissa can correspond to respectiveelectrodes and virtual electrodes of the leadwire in their order ofarrangement along the leadwire.

According to an alternative example embodiment, a three dimensionalgraph is used to plot variations in another, e.g., electrical, settingsin addition to amplitude. A non-exhaustive list of examples of suchparameters include pulse width and frequency. For example, an ‘x’ axiscan correspond to electrode location, a ‘y’ axis can correspond toamplitude, and a ‘z’ axis can correspond to the other parameter, sothat, for example, different amplitude values are plotted for differentvalues of the other parameter at a same electrode position.

As shown in FIG. 10A, in an example embodiment of the present invention,the system is configured to output, in a single graph, curves for boththerapeutic effect (efficacy) and adverse side effect (side effect)measured at multiple actual and/or virtual electrodes of leadwire 200,which curves can intersect depending on the respective minimum andmaximum amplitude values of the curves in the different locations aboutthe leadwire. A user can thereby determine a range of amplitudes andlocations about the leadwire at which to set the stimulation. In anexample embodiment, the system is configured to graphically identify agraph region determined to be suitable for stimulation based on therelationship between the area of the two graphs (where the graphs doindicate the existence of such a region). For example, the processoridentifies electrode locations for which associated minimum therapeuticeffect amplitude values have been recorded which are lower than sideeffect amplitude values recorded for the respective electrode locations,identifies the graph area between those values at the respective plottedelectrode locations, and displays graphical indicia at the identifiedgraph area. A non-exhaustive list of examples of such indicia includecoloring, shading, and/or hatching.

The efficacy curve 101 indicates amplitude thresholds at (or above)which a therapeutic result is expected, depending on the electrode orother longitudinal leadwire position (virtual electrode) at which therespective stimulation amplitude is set. The side effect curve 102indicates a maximum stimulation amplitude at respective electrode orvirtual electrode positions, above which the stimulation is expected tocause an adverse side effect (e.g., above a maximum threshold for suchan adverse side effect). Information on which the curves 101 and 102 arebased can include empirically obtained data and/or model-based data. Thecurves 101 and 102 can be specific to an indicated desired therapyand/or to an indicated adverse side effect. For example, the graphicaluser interface, e.g., in a target settings section, can include an inputfield for inputting a desired therapeutic effect and/or side effect tobe avoided, and output a graph such that shown in FIGS. 10A and 10B asinformation on which basis the user, e.g., a clinician, can determinesettings to set in the system for producing a stimulation. The user canthen select the settings for the leadwire electrodes by clicking on thelocation on the graph that appears to provide the largest therapeuticwidth, i.e. the location where there is the highest probability ofefficacy combined with the lowest probability of an undesiredside-effect. According to an example embodiment, the determination ofthe location where there is the highest probability of efficacy combinedwith the lowest probability of an undesired side-effect is performed bya processor based on information from curves 101 and 102.

In an example embodiment of the present invention, the graphs arecontinuously updated as more data points are added via theabove-described method of e-trolling. The curve begins as a simplestraight line fit between the identified and annotated locations and asmore data are added other curve-fitting techniques can be used to bettermatch the recorded values. Curve fitting is the process of constructinga curve, e.g., by use of a mathematical function, which is a best fit toa series of data points, possibly subject to constraints. Curve fittingcan involve, e.g., interpolation, where an exact fit to the data isrequired, or smoothing, in which a “smooth” function is constructed thatapproximately fits the data. Any suitably appropriate curve fittingfunction may be used. Accordingly, the output graph, in an example,embodiment, plots information for electrode locations for whichtherapeutic and/or side effect data has not been obtained, by “fillingin” such information based on the information obtained for surroundingelectrode locations.

According to an example embodiment, the graphs are also and/oralternatively continuously updated to plot different amplitude valuesfor the therapeutic and or side effect curves for those locations forwhich input had been previously received, and for which the plottedvalues had previously reflected such previously obtained input, as moredata are added for the previously identified and annotated location. Forexample, different results may be observed for settings for an electrodelocation at different times. Because of the variability in measuredeffects for a subject at a given stimulation location it is beneficialto overwrite any previous side effect threshold values for the locationwith a lower side effect threshold value for that location so that theuser may be more sure about selecting stimulation parameters that willnot cause undesired side effects. Likewise, it is beneficial tooverwrite any previous efficacy threshold values for the location with ahigher efficacy threshold value for that location so that the user maybe more sure about selecting stimulation parameters that will producetherapeutic results, e.g. lessen undesired side effects. (Alternatively,averages can be plotted and/or the values to be plotted can becalculated based on a score affected by values of neighboring electrodelocations.) Alternatively, time can be used as a third dimension, sothat a user is able to see a history of the values.

The two-dimensional graph of FIG. 10A does not reflect variations inamplitude at different directions cylindrically about the leadwire 200using directional electrodes. Therefore, according to an alternativeexample embodiment of the present invention, a two-dimensional graph isprovided, where the positions along the abscissa represent locationsfrom a first position of the leadwire 200 circumferentially towardsanother position on the leadwire 200, and where the locations are thoseof respective ones of actual directional electrodes (e.g., 201-203) andvirtual directional electrodes arranged circumferentially on a samelongitudinal level of the leadwire 200. In example embodiment, severalsuch graphs are provided, each for a respective longitudinal level alongthe leadwire 200.

According to an alternative example embodiment, a two-dimensional graphis output, where positions along the abscissa represent longitudinallocations along the leadwire 200, as described above with respect toFIG. 10A, but where one or more of the represented longitudinallocations are respective longitudinal levels at which a plurality ofdirectional electrodes are arranged, with the amplitude information forthe therapeutic effect and side effect corresponding to respectivecombinations of the directional electrodes at the representedlongitudinal locations. Others of the represented longitudinal locationscan be those at which cylindrically symmetrical electrodes are located.The plotted amplitude levels for the levels at which directionalelectrodes are located are those generated by one or a combination ofthe directional electrodes at the respective longitudinal level.Accordingly, some information (i.e., directionality) is missing from thegraph for the represented longitudinal levels at which directionalelectrodes are arranged. For example, in an example embodiment, one ormore of the longitudinal positions correspond to those at whichcylindrically symmetrical electrodes are located, so that directionalityis not a factor, while one or more other longitudinal positionscorrespond to those at which directional electrodes are located, withdirectionality not being indicated.

According to an alternative example embodiment of the present invention,the system generates and outputs a three-dimensional graph, withamplitude plotted as radii, as shown in FIG. 3, with multiple layers ofsuch graphs in combination providing a three-dimensional graph volume,as described above, in order to graphically indicate variations of theamplitude values for the therapeutic effect and side effect at differentcombinations of longitudinal and rotational electrode locations. Thatis, according to this embodiment, the therapeutic effect and adverseside effect information for the steered locations are plotted to showvariations along both longitudinally steered locations and rotationallysteered locations.

According to this embodiment, the system and method outputs stimulationamplitude information in a three dimensional coordinate system in whicheach plotted data point is identified by a longitudinal position ‘z’,angle of rotation ‘θ’, and radius from center ‘r’ as shown by theindicated coordinate system of FIG. 2. The longitudinal position is thelongitudinal position along the central axis of the leadwire, e.g., adistance from one of the ends, the angle of rotation is an angle betweena selected direction extending outward from the leadwire,perpendicularly to the central axis thereof, and the direction in whichstimulation is characterized as being produced by an electrode (orcombination of electrodes), and radius is a distance from the leadwirealong the direction in which the stimulation is characterized as beingproduced. The radius coordinate corresponds to the stimulation amplitudevalue, whereas the longitudinal position and angle of rotationinformation indicates the location of that stimulation. In an exampleembodiment of the present invention, a computer system provides agraphical user interface in which amplitude settings for a directionalelectrode leadwire are plotted in curves at planes that areperpendicular to the central axis of the leadwire according to thedescribed coordinate system including longitudinal, angular, and radiivalues.

In an example embodiment of the present invention, the system includes acontrol selectable for toggling between a three dimensional view of thegraphs and two dimensional views of the graphs.

As noted above, there may be certain adverse side effects that aretolerable for a certain subject and there may be certain therapeuticeffects that are insignificant for said subject. Therefore, in anexample embodiment, the system includes a user interface via which auser can select one or more side effects and/or one or more therapeuticeffects on which basis to generate the graphs.

Such graphs can be useful for a clinician to eyeball a target range ofpossible target stimulation settings for one or more of the electrodes.For example, with respect to the graph shown in FIG. 10A, the clinicianlikely would choose to try stimulation (amplitude+electrode location)settings that fall at about the center of the shaded area 105 betweenthe curves 101 and 102 since it is that region that is expected toproduce a therapeutic effect and to avoid production of an adverse sideeffect.

According to an example embodiment of the present invention, the graphis output as a user-interactive display, where positions within thegraph are user-selectable as an instruction to set electrode parameters.For example, as shown in FIG. 10B, in an example embodiment of thepresent invention, the user interface is configured for the user topoint and click on a location within the graph, the selected locationbeing identified in FIG. 10B as location 106, which the user (or system)has determined is likely a location with a high side effect thresholdand a large therapeutic width (low efficacy threshold). The system isconfigured to, responsive to the selection, automatically choose acombination of electrode location and amplitude (and/or otherstimulation parameter) associated with the selected point 106 on thegraph, for output of the identified parameters in a user interfaceand/or for setting of the leadwire 200 to produce a stimulationaccording to such parameters.

FIG. 11 shows a representation of a plurality of independentlycontrollable current sources 212 for respective ones of the electrodesof the leadwire 200, where the current steering described above, forsteering of the current to virtual electrode positions (longitudinallyand/or rotationally), is possible by setting the amplitudes of differentones of the current sources 212 to different settings. For example, forsettings corresponding to the selected location 106, the system isconfigured to choose the combination of electrode location and amplitude(and/or other stimulation parameter) associated with the selected point106 on the graph as a combination of current amplitude values for arespective combination of the current sources 212. The independentlycontrollable current sources 212 for the respective electrodes can beactivated in accordance with the stimulation settings associated withselected point 106, e.g., for an amplitude of 3.85 mA and virtualelectrode location 1.7, which is closer to the second electrode 211 ofleadwire 200 than to the first electrode 210. The stimulation currentsettings required to localize the stimulation in the area of the virtualelectrode associated with the selected point 106 are determinedautomatically by the system once the point 106 is selected by a user. Inan example embodiment of the present invention, the system uses datapreviously recorded during the e-trolling, regarding the stimulationcurrent settings required to localize the stimulation in the area of thevirtual electrode associated with the selected point, if it is availablefor the selected point. In the example of FIG. 11, electrode 210receives 13% of the max current and electrode 211 receives 87% of themax current so that the stimulation is localized at an electrodelocation corresponding to a virtual electrode located longitudinallybetween cylindrically symmetrical electrodes 210 and 211 and closer toelectrode 211 than to electrode 210.

In an example embodiment of the present invention, a leadwire 200utilizing a single current source for all of the electrodes of theleadwire 200 is used, and after the user has selected a point associatedwith stimulation parameters and clinical data on a graph providedaccording to the user interface described for virtual electrodesteering, the system uses pulse interleaving to approximate thestimulation localized in an area of the corresponding virtual electrode.The pulse interleaving uses a single current source that alternatesbetween different current settings at high speed for the differentelectrodes of the leadwire 200, to provide the different currentamplitudes to different ones of the electrodes of leadwire 200 in analternating manner. In this way, the separate electrodes (e.g., 210 and211) can receive short-timed pulses from the same current source atdifferent current values (e.g., 13% and 87%) so that stimulation islocalized in an area of the corresponding virtual electrode.

As described in detail above, in an example embodiment of the presentinvention, for a set of stimulation parameters, the system outputs agraphical representation of the parameters in the form of a rayextending from a model of the leadwire, where the directionality andlength of the ray represents, respectively, a directionality of thestimulation produced by the parameters and the electrical amplitude. Inan example embodiment, the system additionally outputs informationregarding tissue stimulation produced by the electrical stimulationparameters represented by the array. For example, in an exampleembodiment, the system displays a first user interface frame identifyingone or more of the stimulation parameters and/or including a graphicalrepresentation thereof, e.g., in the form of the described graphicalinformation, and further displays a second user interface sectiondisplaying an estimated VOA, e.g., as described in the '330, '312, '340,'343, and '314 applications, corresponding to the indicated and/orrepresented stimulation parameters.

An example embodiment of the present invention is directed to one ormore processors, which can be implemented using any conventionalprocessing circuit and device or combination thereof, e.g., a CentralProcessing Unit (CPU) of a Personal Computer (PC) or other workstationprocessor, to execute code provided, e.g., on a hardwarecomputer-readable medium including any conventional memory device, toperform any of the methods described herein, alone or in combination,and to generate any of the user interface displays described herein,alone or in combination. The one or more processors can be embodied in aserver or user terminal or combination thereof. The user terminal can beembodied, for example, as a desktop, laptop, hand-held device, PersonalDigital Assistant (PDA), television set-top Internet appliance, mobiletelephone, smart phone, etc., or as a combination of one or morethereof. Specifically, the terminal can be embodied as a clinicianprogrammer terminal, e.g., as referred to in the '330, '312, '340, '343,and '314 applications. Additionally, as noted above, some of thedescribed methods can be performed by a processor on one device orterminal and using a first memory, while other methods can be performedby a processor on another device and using, for example, a differentmemory.

The memory device can include any conventional permanent and/ortemporary memory circuits or combination thereof, a non-exhaustive listof which includes Random Access Memory (RAM), Read Only Memory (ROM),Compact Disks (CD), Digital Versatile Disk (DVD), and magnetic tape.

An example embodiment of the present invention is directed to one ormore hardware computer-readable media, e.g., as described above, havingstored thereon instructions executable by a processor to perform themethods and/or provide the user interface features described herein.

An example embodiment of the present invention is directed to a method,e.g., of a hardware component or machine, of transmitting instructionsexecutable by a processor to perform the methods and/or provide the userinterface features described herein.

The above description is intended to be illustrative, and notrestrictive. Those skilled in the art can appreciate from the foregoingdescription that the present invention can be implemented in a varietyof forms, and that the various embodiments can be implemented alone orin combination. Therefore, while the embodiments of the presentinvention have been described in connection with particular examplesthereof, the true scope of the embodiments and/or methods of the presentinvention should not be so limited since other modifications will becomeapparent to the skilled practitioner upon a study of the drawings,specification, and the following listed features.

What is claimed is:
 1. A method for selecting electrical stimulationparameters for a leadwire implanted in patient tissue and comprising aplurality of electrodes, wherein the plurality of electrodes comprisesat least one set of two or more directional electrodes, wherein thedirectional electrodes of each set are disposed at a same longitudinallevel of the leadwire but at different circumferential positions, themethod comprising: for each of a plurality of values for a particularstimulation parameter, each value corresponding to a respective currentfield produced by a respective combination of one or more of theelectrodes of the leadwire, obtaining, by a computer processor, clinicaleffect information regarding a respective stimulation of the patienttissue produced by the respective current field; displaying a graphplotting the obtained clinical effect information as respective datapoints, wherein each data point is characterized by an angle of rotationand a radius from a center of the graph, wherein the radius correspondsto the value for the particular stimulation parameter associated withthe data point and the angle of rotation corresponds to a directioncharacterizing the current field associated with the data point;receiving a user selection of a point on the graph, wherein the pointcorresponds to a first value of the particular stimulation parameter anda first combination of one or more of the electrodes of the leadwire;initiating a signal, by the computer processor, to program animplantable pulse generator with the first value of the particularstimulation parameter and the first combination of the one or more ofthe electrodes on the leadwire to produce a stimulation; and stimulatingpatient tissue using the programmed implantable pulse generator, thefirst value of the particular stimulation parameter, and the firstcombination of the one or more of the electrodes on the leadwire.
 2. Themethod of claim 1, wherein, for each of the data points, the directioncharacterizing the current field associated with the data point arisesfrom the circumferential position of one or more of the electrodesassociated with the data point.
 3. The method of claim 1, wherein thegraph is three dimensional and each data point is characterized by alongitudinal position corresponding to a longitudinal position of thecurrent field along a central axis of the leadwire.
 4. The method ofclaim 1, further comprising positioning, by the computer processor, therespective current field at each of the respective combinations of oneor more of the electrodes of the leadwire.
 5. The method of claim 4,wherein the positioning is performed by shifting the current field atleast one of longitudinally or rotationally.
 6. The method of claim 5,wherein the shifting is performed in response to user input of a shiftinstruction by selection of a control, each selection of which isinterpreted by the computer processor as an instruction to shift in arespective direction by a predetermined amount.
 7. The method of claim1, wherein the particular stimulation parameter is amplitude.
 8. Themethod of claim 1, wherein the particular stimulation parameter is oneof i) pulse width or ii) frequency.
 9. The method of claim 1, whereinthe obtained clinical effect information includes therapeutic effectvalues and adverse side effect values.
 10. The method of claim 9,further comprising identifying within the graph, a region whose plottedtherapeutic effect values are lower than its adverse side effect values,with a greatest distance between the therapeutic effect values and theadverse side effect values.
 11. A system for selecting electricalstimulation parameters, the system comprising: a leadwire configured forimplantation in patient tissue and comprising a plurality of electrodes,wherein the plurality of electrodes comprises at least one set of two ormore directional electrodes, wherein the directional electrodes of eachset are disposed at a same longitudinal level of the leadwire but atdifferent circumferential positions; an implantable pulse generatorcoupled to the leadwire and configured to stimulate the patient tissueusing the leadwire; a screen; a computer processor coupled to the screenand configured to: for each of a plurality of values for a particularstimulation parameter, each value corresponding to a respective currentfield produced by a respective combination of one or more of theelectrodes of the leadwire, obtain clinical effect information regardinga respective stimulation of the patient tissue produced by therespective current field; display, on the screen, a graph plotting theobtained clinical effect information as respective data points, whereineach data point is characterized by an angle of rotation and a radiusfrom a center of the graph, wherein the radius corresponds to the valuefor the particular stimulation parameter associated with the data pointand the angle of rotation corresponds to a direction characterizing thecurrent field associated with the data point; receive a user selectionof a point on the graph, wherein the point corresponds to a first valueof the particular stimulation parameter and a first combination of oneor more of the electrodes of the leadwire; and initiate a signal toprogram the implantable pulse generator with the first value of theparticular stimulation parameter and the first combination of the one ormore of the electrodes on the leadwire to produce a stimulation; whereinthe implantable pulse generator and leadwire are configured and arrangedto stimulate the patient tissue, when programmed, using the first valueof the particular stimulation parameter and the first combination of theone or more of the electrodes on the leadwire.
 12. The system of claim11, wherein, for each of the data points, the direction characterizingthe current field associated with the data point arises from thecircumferential position of the one or more of the electrodes associatedwith the data point.
 13. The system of claim 11, wherein the graph isthree dimensional and each data point is characterized by a longitudinalposition corresponding to a longitudinal position of the current fieldalong a central axis of the leadwire.
 14. The system of claim 11,wherein the computer processor is further configured to position therespective current field at each of the respective combinations of theone or more of the electrodes of the leadwire.
 15. The system of claim14, wherein the positioning is performed by shifting the current fieldat least one of longitudinally or rotationally.
 16. The system of claim15, wherein the shifting is performed in response to user input of ashift instruction by selection of a control, each selection of which isinterpreted by the processor as an instruction to shift in a respectivedirection by a predetermined amount.
 17. The system of claim 11, whereinthe particular stimulation parameter is amplitude.
 18. The system ofclaim 11, wherein the particular stimulation parameter is one of i)pulse width or ii) frequency.
 19. The system of claim 11, wherein theobtained clinical effect information includes therapeutic effect valuesand adverse side effect values.
 20. The system of claim 19, wherein thecomputer processor is further configured to identify within the graph, aregion whose plotted therapeutic effect values are lower than itsadverse side effect values, with a greatest distance between thetherapeutic effect values and the adverse side effect values.